The Medical Technology Blog

Once again a warm welcome back to The Medical Technology Blog, brought to you by Espicom Business Intelligence. I hope you found my last post on Early ACL Repair of interest. Today’s post concerns the company Cook Medical, Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Please read on….

Cook Medical has pointed out two independent clinical studies that show its BIGopsy backloading biopsy forceps are able to obtain larger tissue samples for biopsy and can lead to an improved ability to diagnose the cause of suspicious ureteral or kidney lesions. The results of both studies were presented at the 2010 American Urological Association (AUA) annual meeting in San Francisco, CA.

The BIGopsy device allows for removal of tissue specimens up to 4 mm3 in size, which is four times the size of samples taken with existing forceps. This larger sample can lead to first-time diagnosis negating the need for repeated procedures that result from an inadequate tissue sample.

In the first study, conducted by Shaun Wason, Alan Schned, John Seigne and Vernon Pais Jr at Dartmouth Medical School, compared the diagnoses resulting from tissue samples taken with the BIGopsy forceps versus the market-leading forceps. Researchers used ex vivo nephroureterectomy specimens to obtain tissue samples for biopsy. The BIGopsy samples were significantly larger than those obtained with the other biopsy forceps (average sample size of 31.2 +/- 34.6 mm2 vs 3.5 +/- 2.8 mm2). Unlike the competitor device, the BIGopsy specimens were accurately identified in all pathology reports.

Competitive biopsy forceps were used to obtain a total of six biopsy samples from three different specimens. The samples ranged in size from 1 to 8 mm2 with an average size sample size of 3.5 +/- 2.8 mm2. Using the same three specimens, BIGopsy was used to obtain five samples with sizes ranging from 6 to 80 mm2 with an average sample size of 31.2 +/- to 34.6 mm2, resulting in an average size that was about nine times larger than market leading biopsy forceps. In all three cases, the test results derived from BIGopsy agreed with the final pathological report. Unlike BIGopsy, samples from the other biopsy device agreed in two cases but disagreed in the third. The smaller sample resulted in the tissue being mis-assigned as malignant.

In addition to their pathological conclusions, the researchers found the BIGopsy tissue specimens were less distorted and fragmented, making them easier for pathologists to interpret. The researchers concluded that improved biopsy quality may translate into improved ability to diagnose ureteral and renal pelvic mucosa lesions endoscopically.

A second study presented by Saeed Al-Qahtani, Dorian Legraverand, Sixtina Gil-Diez de Medina, Malthilde Sibony and Professor Olivier Traxer conducted at the Hôpitol Tenon in Paris, France, also compared the biopsy sample quality of the BIGopsy biopsy forceps to the market leader for upper-tract urothelial tumours. A total of 14 patients were biopsied using both types of forceps and a single pathologist then analysed the blinded samples. The histopathology results of the biopsies performed with BIGopsy were of equal or better quality than biopsies performed with the other brand of biopsy forceps.

In their conclusions, the researchers noted that their study demonstrates the advantage of BIGopsy and recommended the device for the evaluation of upper urinary tract transitional cell carcinoma (UTT-TCC), especially in the case of conservative treatment.

Congratulations to Cook Medical on these results, half day today at CM and beers on the management I reckon.

That’s all for this week, hope you have a fabulous weekend wherever you are, thank you for reading my humble blog, Paul.

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